Vapes: compliance and enforcement

Overview

From 1 July 2024, the regulation of vaping goods in Australia has changed. The TGA is working closely with the Australian Border Force and states and territories on a national collaborative approach to compliance activities and enforcement of the new vape laws.

In addition to seizure and loss of product, significant penalties can apply to the unlawful importation, manufacture, supply, commercial possession and advertising of vaping goods. It is important to familiarise yourself with the information on this website which outlines the regulatory requirements for the lawful supply chain for vaping goods.

Information is provided for importers, transport and storage providers, wholesalers, retailers, prescribers and pharmacies.

These reforms do not criminalise possession of vaping goods by individuals for personal use. New prohibitions on possessing vapes are targeted at the commercial and retail dealers of unlawful vaping goods and black market supply chains, and do not penalise individual users who genuinely possess vaping goods for their own use. If you are an individual, please see the information for patients page for further details.

National Vaping Enforcement Framework

The National Vaping Enforcement Framework was formally endorsed by the National Vaping Working Group on 20 May 2024. The Framework was agreed by the Therapeutic Goods Administration (TGA), the Australian Border Force (ABF), the Australian Federal Police and all state and territory health departments and police forces.

The Framework outlines how Commonwealth agencies, state and territory health departments and police will work together to enforce the vaping reforms, including establishing operational mechanisms and information sharing to support an interconnected and united approach to enforcement.

The Framework will be underpinned by action. This includes working together to use the powers under the Therapeutic Goods Act 1989 (the Act) and state and territory legislation (as appropriate) to conduct enforcement operations and promote consistent approaches between jurisdictions to proactively detect and disrupt unlawful activity.

The Framework outlines the roles and responsibilities of Commonwealth agencies, state and territory health departments and police and sets out governance arrangements.

The Australian Border Force (ABF) will monitor the border and seize any disposable vapes or vaping goods imported without the appropriate licenses. The TGA plays an important role to consider referrals from the ABF for escalated enforcement action regarding import offences.
The TGA also takes primary carriage in relation to advertising compliance.

The states and territories take primary carriage in relation to wholesale and retail supply, with support and cooperation from the TGA.

Health departments are supported by the police forces, with the police playing an important role in relation to organised crime.

The Framework also outlines how the Australian Government’s reforms support enhanced enforcement action, the powers available to undertake compliance and enforcement activity and the delegation of these powers. It identifies risks to be managed, and supports joint activity and operational planning, information and intelligence sharing, and inter-agency agreements.

National Vaping Working Group

In November 2023, the Minister for Health and Aged Care announced the formation of a multi-agency National Vaping Working Group to oversee the development and implementation of the national vaping enforcement framework.

The working group is co-Chaired by the Commissioner of the Australian Border Force, and Secretary of the NSW Ministry of Health. It includes representatives from Commonwealth, state and territory health and police departments, and the Australian Border Force. The Therapeutic Goods Administration represents the Department of Health and Aged Care and provides Secretariat support.

The National Vaping Working Group held its first meeting on 30 January 2024. Communiques are published following each meeting.

Compliance and enforcement

The Australian Government has provided funding to the Australian Border Force and the TGA to enforce these reforms. Compliance and enforcement operations are already underway with further activity planned, including joint operations with state and territory partners.

The changes to the regulation of vaping goods will make it easier for compliance officers, inspectors and investigators to identify unlawful vaping goods.

• Imports of vaping goods without a license and permit may be seized at the border and destroyed. Personal importation is no longer allowed.
• The regulations apply to all vaping goods, meaning that laboratory testing for the presence of nicotine is no longer required.
• Only therapeutic vapes notified to the TGA as compliant with the relevant product standards can be imported, manufactured, and supplied, unless an exemption applies. See [page 5], [page 6a], [page 6b] and [page 7] for further detail. A list of notified products is maintained on the TGA website.
• Vaping goods can only be supplied to consumers through pharmacies. Tobacconists and convenience stores can no longer stock, supply or sell vapes.

The advertising of vaping goods is banned, unless expressly permitted by the Therapeutic Goods (Vaping Goods – Advertising) Authorisation 2024. An authorisation to advertise notified therapeutic vaping goods is only permitted in very limited circumstances. Advertising will be monitored and action taken to address the unlawful promotion of vaping goods.

These changes to the regulatory requirements, while being important public health measures, will also make it easier for relevant agencies to act in relation to non-compliance.

The TGA uses a range of approaches and powers to enforce the Therapeutic Goods Act 1989. This includes education, warning letters, seizure of goods under warrant, infringement notices, and where necessary criminal prosecution and civil penalty proceedings.

To support the work of the TGA and state and territory partners, enforcement powers have been enhanced as part of the reforms.

• A new power to issue an enforceable direction has been introduced. Directions can be issued in relation to:
  • labelling and packaging
  • destruction or disposal
  • delivery of the goods to a specified person to be destroyed or disposed of
  • other matters prescribed by the regulations.
• Goods seized under warrant may be forfeited to the Commonwealth if the Secretary of the department believes on reasonable grounds that there has been a contravention of the Act or non-compliance with an instrument made under the Act.
• Samples of therapeutic vapes must be provided on request for compliance testing.
• Information gathering powers have been enhanced.
• Information sharing powers have also been enhanced.

Relevant enforcement powers under the Therapeutic Goods Act 1989 are delegated to state and territory officers.

Possession and supply exceptions

The Therapeutic Goods (Vaping Goods – Possession and Supply) Determination 2024 (the Determination) provides exceptions for businesses and individuals to possess and supply vaping goods in certain circumstances without being in breach of relevant offences or civil penalty provisions.

Under the Determination, additional time is available for the:

• surrender of unlawful vaping goods through the TGA business surrender scheme (notification period closed as of 1 September 2024)
• transport, storage or disposal of vapes in certain circumstances
• export of unlawful vapes in certain circumstances
• other limited activities.

These transitional arrangements will operate for a limited period and require certain actions to be taken and strict conditions to be met to qualify for the exception. Where a person is relying upon an exception in the Determination for their possession or supply of vaping goods, credible evidence must be retained to demonstrate compliance with the relevant requirements and conditions.

More information:

• Business surrender scheme underway, notification period ends
• Possession and supply of vaping goods in Australia: Guidance on the legal instrument: Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024

Penalties

From 1 July 2024, new and strong penalties apply for the unlawful importation, manufacture, advertising, supply and commercial possession of vaping goods.

The maximum criminal penalties per contravention are:

• seven years in jail and/or
• 5,000 penalty units (equivalent to $1.65 million for an individual and $8.25 million for a corporation).

The maximum civil penalty per contravention is:

• 7,000 penalty units ($2.31 million) for an individual
• 70,000 penalty units ($23.10 million) for a corporation.

This is based on the penalty unit rate at 7 November 2024. This rate is indexed periodically.

Reporting non-compliance

If you suspect non-compliance in relation to therapeutic goods or their advertising, you can report it to us at any time.